FDA — authorised 10 May 2013
- Marketing authorisation holder: GLAXO GRP LTD
- Status: approved
🇺🇸 Breo Ellipta in United States
FDA authorised Breo Ellipta on 10 May 2013
Marketing authorisations
FDA — authorised 15 September 2015
- Application: NDA204275
- Marketing authorisation holder: GLAXO GRP LTD
- Indication: Labeling
- Status: approved
FDA — authorised 2 December 2022
- Application: NDA209482
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
FDA — authorised 2 June 2023
- Application: NDA203975
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
Breo Ellipta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Breo Ellipta approved in United States?
Yes. FDA authorised it on 10 May 2013; FDA authorised it on 15 September 2015; FDA authorised it on 2 December 2022.
Who is the marketing authorisation holder for Breo Ellipta in United States?
GLAXO GRP LTD holds the US marketing authorisation.